Berry Electronic Tech BM1000 Pulse Oximeter User Manual Palm Pulse Oximeter

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Document ID	2278386
Application ID	znrvaP/IvNWLpIdZF2cohA==
Document Description	Users Manual
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Document Type	User Manual
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Date Submitted	2014-05-28 00:00:00
Date Available	2014-05-28 00:00:00
Creation Date	2014-05-21 07:38:49
Producing Software	Microsoft® Office Word 2007
Document Lastmod	2014-05-23 17:23:26
Document Title	Palm Pulse Oximeter
Document Creator	Microsoft® Office Word 2007
Document Author:	Rachel

Operation Manual
Fingertip Pulse Oximeter
Shanghai Berry Electronic Tech Co., Ltd
Instructions
This manual provides the instructions necessary to operate Fingertip Pulse Oximeter
(hereinafter called as the product) in accordance with its function and intended use.
Observance of this manual is a prerequisite for proper performance and correct
operation, and ensures patient and operator safety.
Content of this manual is subject to change without prior notice.
Issued date: 2013/11/25
Version:
1.0
Statement
The manufacturer is responsible for safety, reliability and performance of this product
only in the condition that:
 All installation operations, expansions, changes, modifications and repairs of this
product are conducted by manufacturer authorized personnel; and
 The electrical installation of the relevant room complies with the applicable
national and local requirements; and
 This product is operated under strict observance of this manual.
Guarantee
Free service scope
 The manufacturer provides free service to any product which conforms to the
warranty regulations.
Chargeable service scope
 The manufacturer’s obligation or liability under his warranty does not include the
service of any factitious damage, or misuse, or irresistible natural disaster, or
delay resulting from the improper use or application of the product, or repairs by
people other than the manufacturer authorized personnel.
Return Policy
In the event that it becomes necessary to return a unit to the manufacturer, please
obtain a return authorization first. Please contact the manufacturer and provides the
model number, serial number, and a brief description of the reason for return. Return
shipments will not be accepted if the serial number is not clearly visible.
The customer is responsible for freight charges when this product is shipped to the
manufacturer for service (including any relevant customs fees or other freight related
charges).
I. Safety Information
WARING
Indicate a potential hazard situation or unsafe practice that, if not avoided, could
result in death or serious injury.
CAUTION
Indicate a potential hazard or unsafe practice that, if not avoided, could result in minor
personal injury or product/property damage.
NOTE
Provide application tips or other useful information to ensure that you get the most
from your product.
WARING










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
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The person who uses the product must receive adequate training before use.
The product is intended only as adjunct in patient assessment. It must be
used in conjunction with clinical signs and symptoms. It is not intended as a
device used for treatment purposes.
When using the product together with the electrical surgery equipment, the
user should pay attention to and guarantee safety of the patient being
measured.
EXPLOSION HAZARD: Do not use the product in the presence of
flammable anesthetics, explosive substances, vapors or liquids.
Make sure not to use the product during MRI (magnetic resonance imaging)
scanning because induced current could potentially cause burns.
The product is without alarm function. Continuous monitoring for a long
time is not suitable.
No modification of this product is allowed.
Use AAA alkaline batteries. Do not use poor quality batteries. Remove the
batteries if the product is not to be used for a long time.
For disposal of the Pulse Oximeter and batteries, follow local regulations or
your hospital’s policy regarding disposal of such accessories. Do not dispose
randomly.
The product is commonly sealed product. Keep its surface dry and clean,
and prevent any liquid from infiltrating it.
The device is precision and fragile. Avoid pressure, knock, strong vibration
or other mechanical damage. Hold it carefully and lightly. If it is not in use, it
should be appropriately placed.
If patient is an intended operator, you must read the operation manual
carefully and understand deeply or consult with the doctor and
manufacturer before using. If you have any discomfort in use, please stop
using immediately and go to the hospital.
The pulse oximeter equipment is calibrated to display functional oxygen
saturation.
NOTE

Important! Before use, carefully read this manual, all safety information and
specifications.
II. Product Feature
1. Simple and convenient usage of product, simple one-touch operation.
2. Small volume, light weight, convenient to carry.
3. Lower consumption, original two AAA batteries can continuously work for 24
hours.
4. Low voltage reminder shows in screen when there’s low battery, may influence
the normal working.
5. The machine will automatically power off when there’s no signal generated.
6. Daily maintenance and calibration is unnecessary, except changing the batteries.
7. Communication can be realized between Bluetooth and computer or mobile
phone.
8. The product will automatically be powered off when no signal generates in the
device for longer than 8 seconds.
III. Applicable people and scope
It is suitable for monitoring adults and children. It is used in the hospital’s operation
room, ICU, clinic section office, out-patient department, sickroom, emergency
treatment. It can also be used in the recovery and health care organizations, the
community medical treatments, the oxygen bars, the family nursing, the physical care
in sports ( you can use the product before or after the sport, but it is not recommended
to use it during the sport).
IV. Intended use
This product can be used to monitoring the physiological signal, included: arterial
oxygen saturation (SpO2), pulse rate (PR) and pulse strength. The product measures
these physiological signals of patients, and further processing, then the numerical
results will be displayed in OLED screen or in the computer interface/mobile phone
with its wireless Bluetooth.
NOTE

If the product is intended to allow direct diagnosis or monitoring of vital
physiological processes, then it is likely to result in the immediate danger to
the patient.
V. Contraindications
The product only applies to adults and children, please don’t use the product for
children under the age of three, infant and neonatal.
The damaged skin tissue can’t be measured.
VI Structure and composition
This product is composed of one fingertip pulse oximeter.
VII. Measurement Principle
SpO2 plethysmogram measurement is employed to determine the oxygen saturation
of hemoglobin in the arterial blood. The SpO2/PLETH parameter can also provide a
pulse rate signal, pulse strength and a plethysmogram wave.
Arterial oxygen saturation is measured by a method called pulse oximetry. It is a
continuous, non-invasive method based on the different spectra absorption of
hemoglobin and oxyhemoglobin (called spectrophotometer principle). It measures
how much light, sent from light sources on the other side.
The sensor measurement wavelengths are nominally 660nm for the Red LED and
940nm for Infrared LED. Maximum optical power output for LED is 4 Mw.
VIII. Cleaning and Disinfection
CAUTION



Never immerse or soak the product.
Exercise caution during cleaning/disinfection to avoid wetting the pins.
We recommend that the product be disinfected only when necessary as
determined by your hospital’s policy, to avoid long term damage to the
product.
 Never use cleaning agents/disinfectants other than the recommended.
 Never permit high-pressure and high-temperature disinfection of the device.
Cleaning
1. Clean the product with cotton or soft cloth moistened with water.
2. After cleaning, wipe off the water with a soft cloth.
3. Allow the product to air dry.
Disinfection
The recommended disinfectants include: ethanol70%,
isopropanol70%, glutaraldehyde (2%)solution disinfectants.
1. Clean the product as instructed above.
2. Disinfect the product with cotton or soft cloth moistened with one of the
recommended disinfectants.
3. After disinfection, be sure to wipe off the disinfectant left on the product with a
soft cloth moistened with water.
4. Allow the pulse oximeter to air dry.
IX. General
Display mode: OLED
Size: 58 (H) × 34 (W) × 30(D)mm
Weight: 50g (include two AAA batteries)
X. Electrical specifications
Working voltage: D.C.2.2 V~D.C.3.4V
Battery Type: Two common 1.5V AAA alkaline batteries.
Power consumption: smaller than 50mA
XI. Parameter Specification
SpO2
Range: 35~100%
Resolution: 1%
Accuracy: ±2%（80%-100%）; ±3%（70%-79%）
PR
Range: 25~250bpm
Resolution: 1bpm
Accuracy: ±2bpm
Low perfusion:
Range: 0.5%~20%
SpO2 accuracy: ±2% (70%~100%)
PR accuracy: 25~250bpm ±2bpm
XII. Environment
Temperature
Operation: 5-40℃
Transportation and storage: -20-70℃
Humidity
Operation: <80%
Transportation and storage: <93%
Altitude
Operation: -390~3012meter (-1254~9882feet)
Transportation and storage: -390~5574meter (-1254~18288feet)
Atmospheric pressure
Operation: 86Kpa~106Kpa
Transportation and storage: 50Kpa~106Kpa
Enclosure flame class: V-0
XIII. Packing list
The standard configuration
Fingertip pulse oximeter
Rope
The Operator manual
1pc
1pc
1pc
Expected service life: three years
XIV. Operating Instructions
CAUTION



Check if the product is in normal condition before monitoring. Do not use
the product once it is found damage.
Don’t put the product on extremities with arterial catheter or venous
syringe.
The product can’t be clipped on the edema and tender tissue.

If no pulse is found or reading is unreasonable, first check the testee’s
condition, and then check the product placement on the finger, finally asking
the qualified engineer to check the product for proper functions.
 Don’t use the product to measure patients whose pulse rate is lower than
30bpm, which may cause incorrect results.
 Make sure no contamination or scar exists in the size where the product is
placed. Otherwise, the measured result may be incorrect because the signal
received by the sensor is affected.
 When used on different patients, the product is prone to crossed
contamination, which should be prevented and controlled by the user.
Disinfection is recommended before using the product on other patients.
 The product is not appropriate for the ceaseless monitoring of the patients.
Prolonged and continuous monitoring may increase jeopardy of unexpected
change of dermal condition such as abnormal sensitivity, rubescence, vesicle,
repressive putrescence, and so on. The uncomfortable or painful feeling may
appear if using the device ceaselessly, especially for the patient of poor
perfusion or immature dermographia by light collimation. It is
recommended that the device should not be applied to the same finger for
over 2 hours.
 Don’t perform SpO2 monitoring and NIBP measurements on the same arm
simultaneously. Obstruction of blood flow during NIBP measurements may
adversely affect the reading of the SpO2 value.
 Testee’s fingernail can’t be too long. Otherwise the finger can’t be inserted
into the sensor to a suitable depth and the SpO2 measurements may be
inaccurate.
 Make sure to place the product on the finger in a correct direction. The LED
part of the sensor should be at the backside of the patient hand and
photodetector part at the inside. Make sure to insert the finger to suitable
depth into the sensor so that the fingernail is just opposite to the light
emitted from the sensor.
 To acquire accurate results, please read data until the product is steadily
placed.
Factors affecting measurement accuracy
 The measurements also depend on absorption of special wavelength ray by
oxidized hemoglobin and deoxyhemoglobin. Concentration of nonfunctional
hemoglobin may affect the accuracy of the measurement,
 Shock, anemia, hypothermia and the application of vasoconstriction drug
may decrease arteria blood flow to an unmeasurable level.
 Pigment, or deep color (for example: nail polish, artificial nails, dye or
pigmented cream) may cause inaccurate measurements.
 Interference of high frequency electricity and bright light may affect the
accuracy of the measurement.
Appearance and Display
Figure 1
Measuring steps
1. Hold the product in one hand with the front panel facing the palm. Put the other
hand’s big finger on the battery cabinet lid’s press sign, press downwards and push
the lid open at the same time. The battery cabinet is opened as shown in Figure 2.
2. Install batteries into the slots per the “+” and “-” symbols as shown in Figure 3.
Cover the lid onto the cabinet and push it upwards to make it close well.
3. Press Clip’s press sign in the figure 1and open the clip. Let the testee’s finger put
into the rubber cushions of the clip, make sure the finger is in the right position as
shown in Figure 4, and then clip the finger.
4. Press the power and function switch button on the front panel to turn on the
product. Using first finger, middle finger or ring finger when doing test. Don’t
shank the finger and keep the testee at case during the process. The readings will
be displayed on the LED screen a moment later as shown in Figure 5.
WARRING


When your finger is plugged into the Oximeter, your nail surface must be
upward.
The results may be wrong if you did not plug the finger thoroughly in the
Oximeter.
Figure 2
Figure 3
Figure 4
Figure 5
Function instructions
a. When the data has been displayed on the screen, change the display direction by
pressing the power and function button again. (as shown in Figure 6)
b. When the product is powered on, long press the power and function button,
Bluetooth function will be started. The Bluetooth indicator light on the top of display
will flicker. (as shown in Figure 7)
c. The product will automatically be powered off when no finger is in the device for
longer than 8 seconds. And switch to another display mode. (as shown in Figure 8)
Figure 6
Figure 7
Figure 8
Communication with computer
a. Open the Bluetooth of the computer, search for the Bluetooth device, the pulse
oximeter’s user name is BerryMed, pairing code is 0000.
b. Check the Bluetooth serial no. when connected, such as com18.
c. Open pc software “SpO2-EN.exe”(as shown in Figure 9)
Figure 9
d. Choose Bluetooth serial no., such as com18. (as shown in Figure 10)
Figure 10
e. Click to open. (as shown in Figure 11)
Figure 11
f. Enter display interface. (as shown in Figure 12)
Figure 12
Communication with mobile phone
a. Open the mobile phone, and double-click SpO2 software icon “
the following interface. (as shown in Figure 13)
”. And enter
Figure 13
b. Click the “Add new users” and enter the following interface. (as shown in Figure
14)
Figure 14
c. Input the user name, click the “Details” and jump the following information table.
(as shown in Figure 15)
Figure 15
d. Input personal information, then click “Save” and enter the following interface.
(as shown in Figure 16)
Figure 16
e. Click “berry” and enter the following interface. (as shown in Figure 17)
Figure 17
f. Click“
Figure 18)
”, search equipment and jump the following interface. (as shown in
Figure 18
g. Wait to search out the equipment, click“BerryMed” and enter the following
interface. (as shown in Figure 19)
Figure 19
h. Click“Pair”, to pair with“BerryMed” and enter the following test interface. (as
shown in Figure 20)
Figure 20
i. If you want to exit the software, click escape key of your mobile phone and jump
the following window. And then click“OK”, exit the software. (as shown in
Figure 21)
Figure 21
XV. Troubleshooting
Trouble
Possible reason
solution
The SpO2 and 1. The finger is not properly 1. Please the finger properly
PR can’t be
positioned.
and try again.
displayed
2. The patient’s SpO2 is too low to 2. Try again; Go to a hospital
normally.
be detected.
for a diagnosis if you are
sure the device works all
right.
The SpO2 and 1. The finger is not placed inside
PR
display
enough.
instable.
2. The finger is shaking or the
testee is moving.
The
device 1. The batteries are drained or
can’t be turned
almost drained.
on.
2. The batteries are not inserted
properly.
3. The device’s malfunction.
The screen is 1. The product is automatically
suddenly off.
powered off when no signal is
detected longer than 10 seconds.
2. Power quantity of the batteries is
exhausted.
1. Place the finger properly
and try again.
2. Let the testee keep calm.
1. Change batteries.
2. Reinstall batteries.
3. Please contact the supplier.
1. Normal
2. Replace the batteries.
XVI. Symbolic meaning
Symbol
Meaning
“CAUTIOUS”! Please refer to the operation manual.
Type BF Equipment.
The product does not contain alarm function.
When the end-user wishes to discard this product, it must be sent to
separate collection facilities for recovery and recycling.
Information of manufacture, including name and address.
Date of manufacture.
European Union for approval.
Serial Number.
Batch Code.
Type Number.
The European Union authorized.
IP21
The product is protected against harmful effects of dripping water
per IEC 60529.
IC Warning
This device complies with Industry Canada licence-exempt RSS standard(s). Operation
is subject to the following two conditions: (1) this device may not cause interference, and (2)
this device must accept any interference, including interference that may cause undesired
operation of the device.
Under Industry Canada regulations, this radio transmitter may only operate using an antenna
of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To
reduce potential radio interference to other users, the antenna type and its gain should be so
chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that
necessary for successful communication.
This device complies with Canadian ICES-003 and RSS-210
“Le présent appareil est conforme aux CNR d'Industrie Canada applicable aux appareils radio
exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil
ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage
radioélectrique subi, meme si le brouillage est susceptible d'en compromettre le
fonctionnement."
Cet appareil numérique de la classe B est conforme à la norme NMB-003 du Canada.
FCC Warning
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must
accept any interference received, including interference that may cause undesired operation.
NOTE 1: This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
-Consult the dealer or an experienced radio/TV technician for help.
NOTE 2: Any changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.
Shanghai Berry Electronic Tech Co., Ltd
Unit C, 1st Floor, 7th Building, No.1188 Lianhang Road, Minhang District,
Shanghai, China 201112
TEL: +86-21-5853 1958
FAX: +86-21-5853 0420
www.berry-med.com
Kingsmead Service limited (UK)
145-157 St John Street,London ,EC1V 4PY(UK)
TEL：044-20-7193 9159 FAX：044-20-7193 9159
www.kingsmead-service.com
If you need additional information, please contact with the company.

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